A pilot study of electromagnetic therapy versus biofeedback-based pelvic floor muscle training for pelvic organ prolapse: A mixed-methods approach

OBJECTIVES: This pilot study aimed to: (1) evaluate the effects of high-intensity focused electromagnetic (HIFEM) therapy on pelvic organ prolapse (POP) symptoms and pelvic floor function; (2) compare outcomes across HIFEM, pelvic floor muscle training (PFMT) with biofeedback and/or electrostimulation, and usual care; and (3) explore participant acceptability of the interventions. MATERIALS AND METHODS: A mixed-methods pilot study was conducted in women aged >20 years with stage I-III POP. Participants were randomized to HIFEM, PFMT, or usual care. The HIFEM group underwent twice-weekly 28-min sessions for eight weeks using a non-invasive electromagnetic chair. PFMT consisted of supervised sessions incorporating biofeedback and/or electrostimulation. Usual care included lifestyle advice. Outcomes were assessed using validated questionnaires for POP symptoms and pelvic floor distress, digital palpation, and transperineal ultrasound. RESULTS: Twenty-eight women completed the study (HIFEM, n = 10; PFMT, n = 9; usual care, n = 9). Compared with usual care, HIFEM significantly improved pelvic floor muscle endurance (p = 0.001), whereas PFMT significantly improved muscle strength (p = 0.034), endurance (p = 0.023), and rapid contractions (p = 0.019). Only HIFEM demonstrated significant improvements in POP symptom severity (p = 0.015) and pelvic floor distress (p = 0.041). No serious adverse events were reported. Participant satisfaction was highest in the HIFEM group (100%). Qualitative analysis supported intervention acceptability, with participants reporting increased pelvic floor awareness, improved symptom control, and enhanced psychological well-being. CONCLUSIONS: Both HIFEM and PFMT with biofeedback appear to be safe, acceptable, and effective non-surgical treatment options for women with POP. Although no significant differences were observed between the two interventions, these findings should be interpreted with caution because of the small sample size. Larger studies are needed to confirm comparative efficacy and inform clinical implementation. CLINICAL TRIAL REGISTRATION NUMBER: NCT06532292. URL OF THE REGISTRATION SITE: https://clinicaltrials.gov/study/NCT06532292?cond=Pelvic%20Organ%20Prolapse&intr=high-intensity&rank=1.